CONTACT-K APTT REAGENT

Plasma, Coagulation Control

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Contact-k Aptt Reagent.

Pre-market Notification Details

• Device ID: K834086
• 510k Number: K834086
• Device Name: CONTACT-K APTT REAGENT
• Classification: Plasma, Coagulation Control
• Applicant: PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GGN
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-28
• Decision Date: 1984-02-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845275000658	K834086	000
00845275000634	K834086	000